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Colono Fiberscope Fc-38V Series

by PENTAX Medical Corporation 2 variants

Ref 04961333237241Model FC-38LV

Active European Union

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-04961333237241 Basic UDI-DI 04961333237241UDI-DIDate14 Apr 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

NorwayIcelandSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaLiechtensteinAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyTürkiyeCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDD Active

EU market availability

Made available in 32 countries, as listed in EUDAMED:

Declared by the manufacturer in EUDAMED for this device version; may not cover every market.

  • Austria since 6 May 1997
  • Belgium since 6 May 1997
  • Bulgaria since 6 May 1997
  • Croatia since 6 May 1997
  • Cyprus since 6 May 1997
  • Czechia since 6 May 1997
  • Denmark since 6 May 1997
  • Estonia since 6 May 1997
  • Finland since 6 May 1997
  • France since 6 May 1997
  • Germany since 6 May 1997
  • Greece since 6 May 1997
  • Hungary since 6 May 1997
  • Iceland since 6 May 1997
  • Ireland since 6 May 1997
  • Italy since 6 May 1997
  • Latvia since 6 May 1997
  • Liechtenstein since 6 May 1997
  • Lithuania since 6 May 1997
  • Luxembourg since 6 May 1997
  • Malta since 6 May 1997
  • Netherlands since 6 May 1997
  • Northern Ireland since 6 May 1997
  • Norway since 6 May 1997
  • Poland since 6 May 1997
  • Portugal since 6 May 1997
  • Romania since 6 May 1997
  • Slovakia since 6 May 1997
  • Slovenia since 6 May 1997
  • Spain since 6 May 1997
  • Sweden since 6 May 1997
  • Türkiye since 6 May 1997

Last checked 27 Oct 2026.

Specification

EUDAMED

Device Name
Colono Fiberscope Fc-38V Series Fc-38LV
Model / Reference
FC-38LV, 04961333237241
Primary DI / UDI-DI
04961333237241
Basic UDI-DI
B-04961333237241
EMDN Code
Z12020601 Colonoscopes
Device Class
Class IIa
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
JP-MF-000005227
Authorised representative
PENTAX Europe GmbH DE-AR-000000006

Other devices from PENTAX Medical Corporation

See all devices from PENTAX Medical Corporation →

Properties

Other properties (11)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No